Needle insertion device

ABSTRACT

The present invention generally provides a device for inserting needles and alleviating the discomfort associated with needle insertion. In certain embodiments, the device is suited for injecting butterfly needles and particularly butterfly needles that are attached to infusion tubing. The patient or caregiver loads a butterfly needle with tubing attached into the base of the drive plunger. The needle with tubing attached is retracted into the housing of the device by retracting the inner plunger. Once retracted, the device is activated and ready to administer a needle into the tissue of a patient. The device is then placed on the location of the skin where injection is desired. The surface that contacts the skin may be textured and may include a contact switch that causes the device to vibrate when slight pressure is applied through contact with the skin. Two trigger buttons in the housing of the device may be depressed to eject the needle at an angle essentially perpendicular to the surface of the skin into the tissue of the patient concurrently with the textured pads contacting the skin and vibrating, distracting the patient from the needle insertion. The inner plunger of the device is then depressed toward the surface of the skin to release the needle from the device. The wings and body of the butterfly may be secured to the skin, for example, with an adhesive such as tape.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is continuation of U.S. patent application Ser.No. 16/551,481 filed on Aug. 26, 2019, now U.S. patent Ser. No. ______,which was a Divisional of U.S. application Ser. No. 14/783,076, filedOct. 7, 2015, now U.S. Pat. No. 10,478,569 issued on Nov. 19, 2019. Thiscontinuation application claims the benefit of U.S. patent applicationSer. No. 14/783,076, filed Oct. 7, 2015, incorporated by reference,which is a National Stage of International ApplicationPCT/US2014/033060, filed Apr. 7, 2014 which claims the benefit under 35U.S.C. § 119(e) to U.S. provisional application Nos. 61/809,391, filedApr. 7, 2013, and 61/972,254, filed Mar. 29, 2014 the contents of eachof which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The subject matter disclosed herein relates to devices for insertingneedles into tissue and methods of use.

BACKGROUND OF THE INVENTION

Certain therapies such as immune globulin therapy can beself-administered by a patient or by a caregiver to a patient in thecomfort of the patient's home. Infusion therapies require the user orcaregiver to insert one or more needles into the patient's body. Whilesome patients have no difficulty self-inserting needles or receivingneedles in their body, other patients are sensitive to the pain of theinjection or are uncomfortable seeing needles or injecting needles intotheir body. In particular, many children have difficulty receivinginfusion therapy due to the pain of needle insertion or fear of needles.

The method in which the needle is injected into the tissue is relevantto preventing pain. Research has shown that the speed of the insertionof the needle is important to protect the tissue layers from rupturingand reduce the pain of the insertion. When a needle is slowly insertedinto the tissue, more rupture events are observed in the tissue ascompared to the rapid insertion of a needle into tissue.

Topical anesthesia is one way to help alleviate the pain at the site ofthe insertion. Topical creams may be applied in advance of the insertionof a needle to help numb the skin. These creams may take some time totake effect and some people are sensitive to components in the creams.Other methods for topical anesthesia include contacting the skin withlow temperatures to numb the area or using vibrations on the surface ofthe skin near the injection site.

Many of the therapies that require infusions are given on a weekly orbiweekly basis and some even more frequently. In order to streamline theinfusion process, it would be helpful to have a device that overcomesmany of the difficulties associated with injecting needles into the bodysuch as alleviating pain, and alleviating patient fears. There remains aneed for a device for injecting needles into patients who are sensitiveto the pain of the injection or are uncomfortable seeing needles orinjecting needles into their body.

SUMMARY OF THE INVENTION

A device for administering a needle to a subject, comprising: a housingcomprising a shell with a distal opening and a proximal opening; a driveplunger occupying the space defined by the shell of the housing and inshifting engagement with the housing, wherein the drive plunger has aproximal end with a handle extending from the proximal opening of thehousing and a distal end dimensioned to receive and deliver a needle; adrive spring associated with the drive plunger such that when the handleis retracted proximally relative to the housing, the drive springcompresses and when the drive plunger is released, the drive plungertravels distally from the force of the drive spring; and a component forrelieving discomfort associated with injecting a needle to the subjectreceiving the injection.

The component for relieving the discomfort to the patient is selectedfrom one or more of a textured pad on the distal surface of the housingand a vibrator component. The device may comprise both a textured pad onthe distal surface of the housing and a vibrator component.

The device may comprise a stop to hold the drive spring in a retractedposition. The stop may be one or more buttons extending from the surfaceof the drive plunger. Depression of the button may release the driveplunger from its retracted state. In certain embodiments, when the driveplunger is released, the needle is injected into the skin of thesubject. When the needle is injected into the skin of the subject, thedistal end of the drive plunger may release the needle from the device.

The distal surface of the drive plunger may be dimensioned to receive abutterfly needle. In certain embodiments, the needle is attached toinfusion tubing. In certain embodiments, the device further comprises aneedle positioned in the distal surface of the drive plunger such as abutterfly needle.

A device for administering a butterfly needle to a subject, comprising:a housing comprising a shell with a distal opening and a proximalopening; a drive plunger occupying the space defined by the shell of thehousing and in shifting engagement with the housing, wherein the driveplunger has a proximal end with a handle extending from the proximalopening of the housing and a distal end dimensioned to receive anddeliver a butterfly needle; and a drive spring associated with the driveplunger such that when the handle is retracted proximally relative tothe housing, the drive spring compresses and when the drive plunger isreleased, the drive plunger travels distally from the force of the drivespring. In certain embodiments, the device further comprises a componentfor relieving discomfort associated with injecting a needle to thesubject receiving the injection.

A device for relieving the pain or discomfort of a subject associatedwith receiving administration of a needle, comprising: a housing with aproximal and distal end wherein the distal end has a distal surface forcontacting skin; one or more textured pads positioned on the distalsurface of the housing for contacting the surface of the skin; avibrator motor and power source associated with the housing such thatthe power source supplies power to the vibrator motor when the motor isactivated; a contact switch on the distal surface of the housing whichactivates the vibrator motor and causes the device to vibrate uponcontact with skin.

FIGURES OF THE INVENTION

FIG. 1 (A) is a first side view of a needle insertion device 100according to certain embodiments, FIG. 1(B) is a cross-sectional viewA-A of a needle insertion device 100 according to certain embodiments,FIG. 1(C) is a top view of a needle insertion device 100 according tocertain embodiments, FIG. 1(D) is a bottom view of a needle insertiondevice 100 according to certain embodiments;

FIG. 2 (A) is a second side view of a needle insertion device 100according to certain embodiments, FIG. 2(B) is a cross-sectional viewB-B of a needle insertion device 100 according to certain embodiments,FIG. 2 (C) is a perspective assembled view of a insertion device 100according to certain embodiments;

FIG. 3 is a perspective, exploded view of a needle insertion device 100according to certain embodiments of the present disclosure, and includesan assembly having a housing 1, a drive plunger 2 associated with adrive spring 3 and an inner plunger 4 wherein the drive spring 3provides the force for advancing the drive plunger 2 and needle into theskin of a subject;

FIG. 4 (A) is a first side view of a needle insertion device 101according to certain embodiments, FIG. 4(B) is a cross-sectional viewA-A of a needle insertion device 101 according to certain embodiments,FIG. 4(C) is a top view of a needle insertion device 101 according tocertain embodiments, FIG. 4(D) is a bottom view of a needle insertiondevice 101 according to certain embodiments;

FIG. 5 (A) is a second side view of a needle insertion device 101according to certain embodiments, FIG. 5(B) is a cross-sectional viewB-B of a needle insertion device 101 according to certain embodiments,FIG. 5 (C) is a perspective assembled view of a insertion device 101according to certain embodiments;

FIG. 6 is a perspective, exploded view of a needle insertion device 101according to certain embodiments of the present disclosure, and furtherincludes textured pads 12, a vibrator motor 10 and power source 11;

FIG. 7 is a perspective, exploded view of a needle insertion device 102according to certain embodiments of the present disclosure, and furtherincludes a contact switch 14 associated with a contact spring 15 whichactivates a vibrator motor 10 upon compression of the contact switch 14;

FIG. 8 is a bottom view of device 102 with the drive plunger 2 in anon-retracted state;

FIG. 9 is a perspective view of the bottom of needle insertion device102 with a butterfly needle with attached infusion tubing loaded intorecessions 16 and 17 in the distal surface of the drive plunger 31 withthe drive plunger 2 in a non-retracted state;

FIG. 10 is a bottom view of device 102 with a butterfly needle withattached infusion tubing loaded into recessions 16 and 17 in the distalsurface of the drive plunger 31 with the drive plunger 2 in anon-retracted state;

FIG. 11 is a perspective view of the bottom of needle insertion device102 loaded with a butterfly needle with the drive plunger 2 in aretracted state;

FIG. 12 is a perspective side view of the needle insertion device 102loaded with a butterfly needle with the drive plunger 2 in a retractedstate;

FIG. 13 is a perspective side view of the needle insertion device 102loaded with a butterfly needle with the drive plunger 2 in anon-retracted state; and

FIG. 14 is a perspective side view of the needle insertion device 102with the inner plunger depressed to eject the butterfly needle from thedevice 102;

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingfigures. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Forexample, any features described in any one of devices 100, 101 and 102may be combined with any features of the other devices. Suchmodifications and variations are intended to be included within thescope of the present invention.

The present invention generally provides a device for inserting needlesand alleviating the discomfort associated with needle insertion. Incertain embodiments, the device is suited for injecting butterflyneedles and particularly butterfly needles that are attached to infusiontubing. The patient or caregiver loads a butterfly needle with tubingattached into the base of the drive plunger. The needle with tubingattached is retracted into the housing of the device by retracting theinner plunger. Once retracted, the device is activated and ready toadminister a needle into the tissue of a patient. The device is thenplaced on the location of the skin where injection is desired. Thesurface that contacts the skin may be textured and may include a contactswitch that causes the device to vibrate when slight pressure is appliedthrough contact with the skin. The vibration and or textured pad maycontact the skin for a period of time suitable to anesthetize the area.Two trigger buttons in the housing of the device may be depressed toeject the needle at an angle essentially perpendicular to the surface ofthe skin into the tissue of the patient concurrently with the texturedpads contacting the skin and vibrating, distracting the patient from theneedle insertion. The inner plunger of the device is then depressedtoward the surface of the skin to release the needle from the device.The wings and body of the butterfly may be secured to the skin, forexample, with an adhesive such as tape.

As used herein, the terms “subject” or “patient” mean the personreceiving the needle injection. In some cases the subject is also apatient receiving a therapy. In other scenarios the subject may not be apatient such as a subject receiving a tattoo or other injectionunrelated to treatment or prevention of a condition.

A “user” of the device means the person who is actively manipulating thedevice. The user may be the subject or patient or the user may be athird party such as a physician or a caregiver.

The “needle” or “needles” described herein refer to any kind of needlesuch as a disk needle, a butterfly needle, a needle associated with acannula, a trocar with a catheter or any other needle injected into theskin.

FIGS. 1-2 illustrate a variety of views of one exemplary embodiment ofthe needle injection device 100. FIGS. 1 and 2 depict device 100 withthe drive plunger 2 in a retracted state. FIG. 3 depicts an explodedview of device 100. As seen in FIGS. 1A-2C and 3 , device 100 comprisesa housing 1 with an inner plunger 4 and drive plunger 2. The driveplunger 2 is associated with a drive spring 3 that provides the forcefor advancing the drive plunger 2 and needle into the skin of a subject,such as a patient.

The housing 1 comprises a shell with a proximal opening 43 and distalopening 44. The space defined by the shell may receive a drive plunger 2such that the drive plunger 2 may be in shifting engagement with thehousing 1. The drive plunger 2 may move in distal and proximaldirections relative to the housing 1. For example, the drive plunger 2may extend from the proximal opening of the housing in certain positionsor from the distal opening of the housing 1 in other positions. Incertain embodiments, drive plunger 2 comprises a cylindrical tube withproximal end 35 and distal end 36 and the tube of the drive plunger 2may define a lumen. The drive plunger 2 may be modified on the proximalend 35 with a handle to allow the user to grasp the handle and extendthe drive plunger distally (not shown). The drive plunger 2 may bemodified on the distal end 36 with a distal surface 31 dimensioned toreceive a needle such as a butterfly needle with infusion tubingattached. The drive plunger 2 may be associated with a drive spring 3,such as a drive spring 3 positioned around the barrel of the driveplunger 2. The drive plunger 2 may be proximally moved by grasping thehandle and pulling the proximal end of the drive plunger through theproximal opening of the housing 43 and thereby compressing the drivespring 3.

In certain embodiments, the device further comprises an inner plunger 4as seen in FIG. 3 . The inner plunger 4 may comprise a handle 42, abarrel and a distal end 19. In certain embodiments, when the devicecomprises an inner plunger 4, the drive plunger 2 is not modified with ahandle. The barrel 37 and distal end of the inner plunger 19 may extendthrough the lumen in the drive plunger 2. The distal end of the driveplunger 36 may define an opening through which the distal end of theinner plunger 19 extends. Protrusions 38 on the distal end of the innerplunger 19 may be dimensioned to lock into the distal end of the driveplunger 36 such that the drive plunger 2 is moved proximally when theinner plunger 4 moves proximally. For example, the distal end of theinner plunger 19 may form a T-shape positioned at the end of the innerinjector barrel 38 on the distal end of the drive plunger 36. TheT-shape, for example, cannot pass through the opening in the distal endof the drive plunger 36 so the T-shape forces the drive plunger 2 tomove proximally when the inner plunger 4 moves proximally.

The drive plunger may be associated with a drive spring 3 such as aspring surrounding the cylinder defining the lumen of the drive plunger2. The drive plunger 2 may be retracted by pulling the handle 42 of theinner plunger 4 to raise the distal end of the drive plunger 36 into thehousing 1. The inner plunger 4 may be manually retracted. For example,the user may hold the housing 1 in one hand and retract the handle 42 ofthe inner plunger 4 with another hand or with the thumb and forefingerof the hand holding the housing 1. As the drive plunger 2 is retracted,the drive spring 3 associated with the drive plunger 2 is compressed.The drive plunger 2 may be held in a retracted position with one or morestops such as trigger buttons, projections, or locks, e.g., triggerbuttons 6 and 7. The one or more stops may extend through windows in thesurface of the housing, e.g., windows 27 and 28, and may prevent thespring from releasing and forcing the drive plunger distally (window 28not shown).

The exterior surface of the cylindrical drive plunger 2 may be modifiedwith one or more stops, e.g., trigger buttons 6 and 7, such that whenthe drive plunger 2 is retracted as in FIGS. 1 and 2 , trigger buttons 6and 7, which may be spring loaded, each protrude from the housing 1,e.g., trigger button 6 protrudes from a window 27 in the housing 1. Whenthe drive plunger 2 is not retracted, the trigger buttons 6 and 7 may beconcealed within the housing 1 between the interior surface of thehousing 1 and the exterior surface of the drive plunger 2. In certainembodiments, the drive plunger 2 is modified with two trigger buttonsand the buttons may be located in positions on the drive plunger suchthat the user may contact the two buttons simultaneously. For example,the two trigger buttons 6 and 7 may be located about 90 degrees up toabout 180 degrees apart from the other one on the cylindrical body ofthe drive plunger 2 such that the buttons may be contactedsimultaneously with a thumb and forefinger. In certain embodiments, theuse of two trigger buttons is preferred to prevent the accidentalrelease of the drive plunger 2 by the compression of one of the buttons.The trigger buttons 6 and 7 may be associated with springs 9 and 8,respectively, which allow each trigger button 6 and 7 to spring out fromthe window in the housing, e.g. trigger button 6 protrudes from a window27, when the drive plunger 2 is retracted. The trigger buttons in theirextended positions may hold the drive plunger 2 in a retracted position.To release the drive plunger 2, the one or more trigger buttons, e.g.,trigger buttons 6 and 7, may be depressed to release the drive plunger 2and the force of the compressed drive spring 3 forces the drive plunger2 and needle into the skin of the patient.

FIGS. 4-5 illustrate a variety of views of an exemplary embodiment of aneedle injection device 101. FIG. 6 depicts an exploded view ofinjection device 101. Distinct from device 100, device 101 comprisestextured pads 12 on the distal surface 30 of the housing 1 of the device101. The distal surface 30 of the housing 1 of the device 101 is theportion of the device 101 that contacts the skin surrounding the site ofthe injection. FIG. 4D depicts the distal surface 30 of the device withtextured pads 12. The distal surface 30 of the housing 1 may be modifiedwith one or more textured pads 12 such as one, two, three or fourtextured pads 12. The texture on the pads may be in the form of multipleprojections on the surface of the pad that extend distally toward theskin of the patient. The projections may extend from 1-3 mm from thesurface of the textured pad 12 such as about 1-2 mm from the texturedpad 12. The projections may terminate in pointed tips such that skincontact with the textured surface distracts the subject from the pain ofneedle insertion. In certain embodiments, the textured pads 12 comprisemultiple plastic spikes, e.g., needle-like projections or tips, whichcontact the skin prior and/or during the time of the injection andanesthetize the surface of the skin and/or distract the patient fromdiscomfort associated with the injection. Such projections may bearranged along a perimeter of the distal surface 30 of the housing 1 orin a radial or grid pattern. Projections may be arranged along a portionof the distal surface 30 of the housing or substantially covering thedistal surface 30 of the housing 1.

Also distinct from device 100, device 101 comprises a power source 11and vibrator motor 10. The power source 11 and vibrator motor 10 may belocated on the housing, e.g., the power source 11 may be located in apocket 39 of the housing 1 that envelops the power source 11. The powersource 11 may be accessed through a door in the pocket 39 of the housing1 that permits access into the pocket 39 with the power source 11. Incertain embodiments, the power source is a battery and the battery islocated in a pocket 39 in the housing 1. The vibrator motor may belocated in a pocket 40 in the housing. The vibrator motor 10 may belocated in close proximity such as adjacent to the power source 11. Incertain embodiments, the vibrator motor 10 is located in proximity tothe distal end 44 of the housing 1. In certain embodiments, the powersource 11 supplies power to the vibrator motor 10 when the motor isactivated.

The vibrator motor 10 may be powered by a power source 11 such asbatteries or mechanical means, e.g., a winding mechanism. In certainembodiments, power may be supplied to the vibration motor 10 from thepower supply 11, e.g., batteries, upon movement between the housing 1and drive plunger 2, for example, upon contact with a conductive contactarea 41. For example, upon pulling back or setting at least one of theinner and drive plungers in a firing position, electrical contact of acontact area 41 enables a completed circuit thereby starting thevibrator motor 10. In some embodiments, the vibrator motor 10 operatesprior to triggering the needle insertion such as several seconds priorto needle insertion to ensure that the active effect of pain lesseningis provided.

The vibrator motor 10 may have a speed of between 60 rpm and 15,000 rpm,or in some embodiments, between about 5000 rpm and 10,000 rpm, and insome embodiments, about 9000 rpm. In certain embodiments, the vibratormotor 10 may have a speed of about 6000 rpm to about 10,000 rpm, such asabout 7,000 to about 10,000 rpm, such as about 8,000 to about 10,000.The vibrator motor 10 may be structured such that upon motor rotation, aweight is placed on a shaft of the motor or connected to the motor shaftto create an out of balance scenario. Thus, upon motor rotation,oscillations of the out-of-balance shaft may create vibrations.

The vibrator motor 10 may be activated, for example, when the innerplunger 4 is retracted or when the trigger buttons 6 and 7 aredepressed. When the vibrator motor 10 is activated, the device 101vibrates. The vibration of the device in contact with the skin of thesubject, distracts the subject from the injection of the needle and/oranesthetizes the skin. In certain embodiments, the device comprisestextured pads 12 and a vibration element such as a vibrator motor 10 andpower source 11. In other embodiments, the device comprises either thevibration element such as the vibrator motor 10 and power source 11 orthe textured pads 12. The device may comprise one or more additionalelements for lessening discomfort of needle insertion or distracting thesubject from the needle insertion.

FIG. 7 depicts an exploded view of an exemplary embodiment of a needleinjection device 102. Distinct from injection device 101, injectiondevice 102 comprises a contact switch 14 for activating the vibratormotor 10. The contact switch 14, is located on the distal end 44 of thehousing 1 and the portion of the contact switch 14 in contact with theskin may be modified with a textured pad such as a pad textured withplastic spikes. When the distal surface 30 of the housing 1 contacts theskin of the patient, the contact switch 14 is depressed and the vibratormotor 10 is activated. The contact switch 14 may be associated with acontact switch spring 15 such that when the contact switch 14 contactsthe skin, the contact spring depresses the contact switch spring 15,resulting in the activation of the vibrator motor 10. Once the contactbetween the skin and the distal end of the housing 1 ceases, thevibrator motor 10 may stop as the spring relaxes to an extended state.

FIG. 8 depicts a bottom view of needle injection device 102. The distalsurface 30 of the housing 1 comprises textured pads 12 such as one, two,three or four textured pads 12. The distal surface of the drive plunger31 comprises recessions 17 and 16 for receiving the wings of a butterflyneedle and infusion tubing, respectively. The distal surface of theinner plunger 19 is located in the interior opening 18 of the distalsurface of the drive plunger 31. The contact switch 14 may include atextured pad surface.

FIG. 9 depicts a perspective bottom view of the needle injection device102 loaded with a butterfly needle in a non-retracted state. FIG. 10depicts a bottom view of the needle injection device 102 loaded with abutterfly needle in a non-retracted state. The body of the butterflyneedle 20 may be positioned in the center of the distal surface of thedrive plunger 31 in contact with the distal surface of the inner plunger19. The body of the needle extends through recession 16 of the distalsurface of the drive plunger 31, while the wings of the butterfly needleare positioned in recessions 17 of the distal surface of the driveplunger 31. Recessions 16 and 17 of the distal surface of the driveplunger 31 may be dimensioned to hold the butterfly needle firmly inplace until release is triggered by the compression of the inner plunger4.

The butterfly needle may be loaded into the distal end of the device byholding the wings together and pushing the body of the butterfly intothe recession in the distal surface of the drive plunger 31 dimensionedto receive the body. The wings may be held together through connectingfeatures such as recession 24 and button 25 on opposing wings 22 and 23.The wings 22 and 23 may then be separated and pushed down into recession17 in the distal surface of the drive plunger 31. Other methods ofloading the butterfly needle into the distal surface of the driveplunger include separating the wings 22 and 23 of the butterfly andpressing the wings 22 and 23 into the recessions 17, in the distalsurface of the drive plunger 31 thereby forcing the body of thebutterfly 20 down into the recession in contact with the distal end ofthe plunger 19.

In certain embodiments, the needle 21 of the butterfly needle isprotected with a sheath such as a plastic sheath. The sheath may be aplastic tube that covers the tip of the needle. The sheath may protectthe user from unintentionally piercing skin with the needle, forinstance, while opening the butterfly wings or loading the butterflyneedle into the device. In certain embodiments, the device may removethe sheath on the needle 21. For example, when the plunger is retractedand the needle is drawn up into the housing of the device, the sheathmay be removed during retraction. Removal of the sheath may occur, forexample, by an arm on the interior of the housing that extends from thehousing toward the needle. When the needle is retracted into the device,the arm may catch the sheath such that the sheath is pulled off of theneedle as the needle retracts and the arm remains stationary, forexample. The sheath may comprise an arm, a projection, or a disk, forexample, which is contacted by the housing during retraction. Acomponent on the interior of the housing such as a detent or projectionmay contact the arm, projection, or disk of the sheath to remove thesheath during retraction.

FIGS. 9 and 10 depict needle insertion device 102 in a non-retractedloaded state wherein the drive plunger 2 and inner plunger 4 are notretracted and a butterfly needle is loaded into the distal recessions 16and 17 of the drive plunger 2.

FIGS. 11-12 depict the device 102 in its activated and loaded state. Thedevice is loaded when a needle is positioned in the recessions 16 and 17in the distal end of the device. To activate the device, the innerplunger 4 may be retracted. To retract the inner plunger 4, the housing1 may be held in one hand the inner plunger 4 may be pulled in aproximal direction away from the housing 1. The inner plunger 4 and thedrive plunger 2 may move together in the proximal direction such thatthe distal portions of the drive plunger 2 and inner plunger 4 retracttogether into the interior of the housing when the inner plunger 4 isproximally retracted. As the inner plunger is retracted, the drivespring 3 is compressed.

Trigger buttons 6 and 7, which are concealed inside the housing when thedevice is not activated, protrude from windows 27 and 28 in the housingof the device in its activated state (window 28 not shown). Triggerbuttons 6 and 7 may be attached via springs 9 and 8, respectively, tothe exterior of the body of drive plunger 2. In the non-activated statewhen the plunger is not retracted, a trigger button may rest in arecession in the interior surface of the housing. For example, in FIG.11 , recession 29 may receive trigger button 7 in the non-activatedstate. The protrusion of trigger button 7 into the recession 29 may helpprevent the plunger from retracting into the housing when the needle isbeing loaded into the device in its non-retracted state. A correspondingrecession in the interior of the housing may be present to receivetrigger button 6 when the device is in its non-activated state. Thecontact between the one or more trigger buttons and the one or morerecessions on the interior surface of the housing may provide resistanceagainst proximal movement of the drive plunger 2.

When the plunger is retracted to the point where the trigger buttons 6and 7 may protrude from windows 27 and 28, the trigger buttons extendout through windows 27 and 28 and the plunger is held in a retractedposition by the protrusion of the buttons from the housing 1. In theretracted or activated state, the wings of a butterfly needle 22 and 23extend outside the housing through channels 32 and 33 in the housing 1.The tubing 26 attached to the butterfly needle may extend out throughchannel 34 of the housing 1 of the device.

As described herein, the device may include various indents, recessesand corresponding projections, one or more pins, one or more prongs, andthe like, for forming a stop, setting point, or firing position. Suchprojections may also be flexible so that they can easily be moved, byfor example design, e.g., a wedge, a slide, etc., to go into a recessand/or come out of such recess to effect one or more functions of thedevice. In some embodiments, the portions are formed as wedge-likemembers, and/or the like, which are received by corresponding recesses.

For example, in some embodiments, upon pulling back on the inner plungerto move at least one of the inner plunger/ejector and drive plunger intoa firing position, certain portions of the inner plunger and/or driveplunger modified with one or more projections are flexed in a firstdirection so that the projections move into a recess. In someembodiments, the one or more trigger buttons can then be arranged tomove the projections out of the recess in, for example, by flexing theprojection in a second direction, so that the spring force is releasedto drive at least one of the inner plunger and drive plunger in adirection for injecting a needle into tissue, and thereby drive theneedle into tissue.

In its activated state, the device may be positioned at a location onthe patient's body intended for needle injection. For example, thedevice may be positioned on a section of the abdomen or the thigh. Thedevice may be positioned substantially perpendicularly to the surface ofthe skin. In certain embodiments, the distal surface 30 of the housing 1is positioned such that all or a substantial portion of the distalsurface 30 of the housing 1 contacts the surface of the skin. Forexample, each of the textured pads or a substantial portion of one ormore textured pads on the distal surface 30 of the housing 1 contactwith the surface of the skin. The device may be pressed against thesurface of the skin. In certain embodiments, the device is pressedagainst the surface of the skin such that a contact switch 14 isdepressed and a vibrator motor is activated.

In certain embodiments, the pain relieving component may be active for aperiod of time prior to the injection of the needle. For example, adevice with textured pads may be pressed against the skin for a periodof about 30 seconds or less, such as about 20 seconds or less, such asabout 10 seconds or less preceding the injection of a needle. In otherembodiments, a device with a vibrator motor may vibrate in contact withthe skin for a period of about 30 seconds or less, such as about 20seconds or less, such as about 10 seconds or less preceding theinjection of a needle. In certain embodiments, a device with both avibrator motor and one or more textured pads may be active for a periodof about 30 seconds or less, such as about 20 seconds or less, such asabout 10 seconds or less preceding the injection of a needle.

As the device is pressed against the surface of the skin at the desiredlocation of injection, the trigger button or buttons may be depressed bythe user. When the trigger buttons are depressed, the drive spring 3 isreleased from its compressed state and the drive plunger together withthe inner plunger may be released to travel in the distal direction. Thetension on the drive spring forces the drive plunger and inner plungerto accelerate rapidly in the distal direction and the drive the needleinto the skin of the patient.

In certain embodiments, the depression of the trigger buttons drives theneedle into the skin of the patient and releases the needle from thedevice. In other embodiments, the needle is not released from recessions16 and 17 in the distal surface of the drive plunger 31 followingdepression of the trigger buttons and an extra step is required torelease the needle body 20 from the device. In certain embodiments, oncethe drive plunger 2 has been released and the needle is positioned inthe tissue of the patient, the body of the needle 20 is released fromthe device by depressing the inner plunger 4. The inner plunger 4 isassociated with an ejector spring 5 that compresses when the innerplunger 4 is depressed and releases the needle from the device. Once theuser stops depressing the inner plunger 4, the plunger springs back toan extended position.

In certain embodiments, the distal end of the inner plunger 19 comprisesprotrusions 38 extending from the distal side of the opening in thedistal end of the drive plunger 19. The protrusions 38 may allow theinner plunger to grab the distal surface of the drive plunger when theinner plunger 4 is retracted such that when the inner plunger 4 isretracted, the drive plunger 2 is concurrently retracted. In the distaldirection, the inner plunger 4 may slide independently in the lumen ofthe drive plunger to eject the needle from recessions 16 and 17 in thedistal end of the drive plunger 31 by contacting the body of the needleand forcing the needle in the distal direction.

In certain embodiments, the inner plunger 4 is associated with anejector spring 5. When the inner plunger 4 is depressed on the device ina non-retracted state in the distal direction, the inner plunger 4compresses the ejector spring 5. The inner plunger 4 travels in thedistal direction such that the protrusions 38 on the distal end of theinner plunger 19 extend distally from the distal surface of the driveplunger 36. As the inner plunger 4 is depressed distally, the body ofthe butterfly needle is pushed out from recessions 16 and 17 in thedistal surface of the drive plunger 31 disconnecting the needle from thedevice. When the user stops depressing the head of the inner plunger,the compression created on the ejector spring 5 forces the head of theinner plunger 4 up to a rested position.

The invention provides methods for administering a needle to a subjectsuch as a patient in need thereof. A user of the device may load thedevice such as any one of devices described herein, e.g., 101, 102 or103, with a needle such as a butterfly needle. The needle may be loadedinto the device by pressing the needle into the recessions in the distalsurface of the drive plunger. Once the device is loaded, the user mayretract the plunger to the point in which the plunger is stopped andheld in a retracted position, for example, by the trigger buttons. Theuser may then position the device on the surface of the skin such thatthe distal surface of the housing contacts the skin. For certainembodiments, the user may press the distal surface of the housingagainst the skin to trigger a distracting or anesthetizing effect of thetextured pads and/or to activate the contact switch of the vibratormotor. The pain relieving component may be active for a period of timepreceding the injection of the needle, such as about 30 seconds or less,about 20 seconds or less or about 10 seconds or less. The user may thenrelease the plunger, for example, by depressing the trigger button orbuttons. In certain embodiments, the plunger may be depressed to releasethe needle from the recessions in the drive plunger. In certainembodiments, the user may secure the needle to the surface of the skinwith an adhesive such as tape. The invention further provides methodsfor relieving the pain of needle injections. In certain embodiments, theinvention provides a device for relieving pain comprising a painrelieving component such as a textured pad and/or a vibrating elements.The device may comprise a housing with a contact switch on the distalsurface such that contacting the distal surface of the device to theskin relieves pain such as the pain of needle injections. In certainembodiments, the device for relieving pain does not also inject aneedle.

Embodiments of the present disclosure may be used, for example, forneedle stick tests for diabetics, intravenous catheter insertion,subcutaneous catheter insertion, blood sampling, superficial surgicalprocedures, and topical anesthesia of leg ulcers for cleansing ordebridement. Also, some embodiments can be used to numb the skin fortattooing as well as electrolysis and laser hair removal.

Although a few variations have been described in detail above, othermodifications are possible. For example, any logic flow depicted in theaccompanying figures and described herein does not require theparticular order shown, or sequential order, to achieve desirableresults. Other implementations may be within the scope of at least someof the following exemplary claims.

Example embodiments of the devices, systems and methods have beendescribed herein. As noted elsewhere, these embodiments have beendescribed for illustrative purposes only and are not limiting. Otherembodiments are possible and are covered by the disclosure, which willbe apparent from the teachings contained herein. Thus, the breadth andscope of the disclosure should not be limited by any of theabove-described embodiments but should be defined only in accordancewith claims supported by the present disclosure and their equivalents.

What is claimed:
 1. A device for administering a needle to a subject, comprising: a housing comprising a shell with a distal opening and a proximal opening, with two opposing grooves extending from the distal opening towards the proximate opening, a distal surface disposed at least partially about the distal opening; a drive plunger occupying the space defined by the shell of the housing and in shifting engagement with the housing, wherein the drive plunger has a proximal end with a handle extending from the proximal opening of the housing and a distal end dimensioned to receive and deliver the needle, the distal end further including depressions aligned to the grooves of the housing to permit a butterfly needle having wings to be received with each wing extending beyond the housing; a drive spring associated with the drive plunger such that when the handle is retracted proximally relative to the housing, the drive spring compresses and when the drive plunger is released, the drive plunger travels distally from the force of the drive spring; and a component for relieving discomfort associated with injecting the needle to the subject receiving the injection.
 2. The device of claim 1, further including an inner plunger occupying the lumen of the drive plunger and comprising a handle extending from the proximal opening of the housing and in connection with the proximal end of the drive plunger, a barrel and a distal end in proximal shifting engagement with the drive plunger such that when the handle of the inner plunger is retracted proximally relative to the housing, the drive plunger is retracted, wherein the drive spring is associated with the drive plunger such that when the handle of the inner plunger is retracted proximally relative to the housing, the drive spring compresses and when the drive plunger is released, the drive plunger travels distally from the force of the drive spring.
 3. The device of claim 1, wherein the component for relieving discomfort further comprises a vibrator motor and power source associated with the housing such that the power source supplies power to the vibrator motor when the motor is activated.
 4. The device of claim 2, wherein the component for relieving discomfort further includes a textured pad on the distal surface of the.
 5. The device of claim 1, further comprising a stop to hold the drive spring in a retracted position.
 6. The device of claim 4, wherein the stop is a button extending from the surface of the drive plunger, depression of the button releasing the drive plunger from its retracted state.
 7. The device of claim 1, wherein when the drive plunger is released, the needle is injected into the skin of the subject.
 8. The device of claim 7, wherein when the needle is injected into the skin of the subject, the distal end of the drive plunger releases the needle from the device.
 9. The device of claim 1, wherein the needle is attached to infusion tubing, the housing further comprising a tubing channel extending from the distal opening towards the proximal opening, the infusion tubing attached to the needle extending through the tubing channel.
 10. The device of claim 1, wherein the distal surface of the housing is divided into at least 2 distinct parts with the channels of the housing therebetween.
 11. A device for administering a butterfly needle having wings to a subject, comprising: a housing comprising a shell with a distal opening and a proximal opening, with two opposing grooves extending from the distal opening towards the proximal opening, a distal surface disposed at least partially about the distal opening; a drive plunger occupying the space defined by the shell of the housing and in shifting engagement with the housing, wherein the drive plunger has a proximal end with a handle extending from the proximal opening of the housing and a distal end dimensioned to receive and deliver a needle, the distal end further including holders for receiving the wings of the butterfly needle, the holders aligned to the grooves of the housing to permit each wing of the butterfly needle to extend from the housing; a drive spring associated with the drive plunger such that when the handle is retracted proximally relative to the housing, the drive spring compresses and when the drive plunger is released, the drive plunger travels distally from the force of the drive spring; and a component for relieving discomfort associated with injecting a needle to the subject receiving the injection.
 12. The device of claim 11, further including an inner plunger occupying the lumen of the drive plunger and comprising a handle extending from the proximal opening of the housing and in connection with the proximal end of the drive plunger, a barrel and a distal end in proximal shifting engagement with the drive plunger such that when the handle of the inner plunger is retracted proximally relative to the housing, the drive plunger is retracted, wherein the drive spring is associated with the drive plunger such that when the handle of the inner plunger is retracted proximally relative to the housing, the drive spring compresses and when the drive plunger is released, the drive plunger travels distally from the force of the drive spring.
 13. The device of claim 11, wherein the recessions in the distal end of the drive plunger are dimensioned to hold the butterfly needle firmly in place.
 14. The device of claim 11, wherein the component for relieving the discomfort to the patient is selected from one or more of: a textured pad on the distal surface of the housing and a vibrator component comprising a vibrator motor and power source associated with the housing such that the power source supplies power to the vibrator motor when the motor is activated.
 15. The device of claim 11, wherein when the drive plunger is released, the butterfly needle is injected into the skin of the subject.
 16. The device of claim 15, wherein when the needle is injected into the skin of the subject, the distal end of the drive plunger releases the needle from the device.
 17. The device of claim 11, wherein the needle is attached to infusion tubing, the housing further comprising a tubing channel extending from the distal opening towards the proximal opening, the infusion tubing attached to the needle extending through the tubing channel.
 18. The device of claim 11, wherein the distal surface of the housing is divided into at least 2 distinct parts with the channels of the housing therebetween.
 19. A device for administering a needle to a subject, comprising: a housing comprising a shell with a distal opening and a proximal opening, with two opposing apertures extending from the distal opening towards the proximate opening, a distal surface disposed at least partially about the distal opening; a drive plunger occupying the space defined by the shell of the housing and in shifting engagement with the housing, wherein the drive plunger has a proximal end with a handle extending from the proximal opening of the housing and a distal end dimensioned to receive and deliver the needle, the distal end further including receivers aligned to the apertures of the housing to permit a butterfly needle having wings to be received with each wing extending beyond the housing; a drive spring associated with the drive plunger such that when the handle is retracted proximally relative to the housing, the drive spring compresses and when the drive plunger is released, the drive plunger travels distally from the force of the drive spring; and a component for relieving discomfort associated with injecting the needle to the subject receiving the injection.
 20. The device of claim 19, further including an inner plunger occupying the lumen of the drive plunger and comprising a handle extending from the proximal opening of the housing and in connection with the proximal end of the drive plunger, a barrel and a distal end in proximal shifting engagement with the drive plunger such that when the handle of the inner plunger is retracted proximally relative to the housing, the drive plunger is retracted, wherein the drive spring is associated with the drive plunger such that when the handle of the inner plunger is retracted proximally relative to the housing, the drive spring compresses and when the drive plunger is released, the drive plunger travels distally from the force of the drive spring. 